Children's Activities and Social Participation

March 11, 2025 updated by: Elisa Beatriz van Eyken, Federal Institute of Rio de Janeiro

Activities and Social Participation of Children With Atypical Motor Development

The goal of this observational study is to learn the perception of caregivers about the limitations of activities, and the restriction in the social participation of children who are in Neurofunctional physiotherapy. The main questions it aims to answer are:

  • What is the ability to perform tasks, and
  • how is the social participation of children with atypical motor development?

Participants will answer two of three questionnaires:

  • The Participation and Environment Measure - Children and Youth or the Young Children's Participation and Environment Measure, depending on the age of their child

.The Pediatric Evaluation of Disability Inventory - PEDI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The limitation in the execution of activities and tasks, as well as the restriction in the social participation of children considered atypical are considered biopsychosocial aspects of health according to the model of the International Classification of Disability and Health Functionality (ICF). The perception of the difficulties and limitations in the execution of the tasks, the barriers and facilitators of the environments and the participation and its restrictions, can be important to follow minimal or expressive improvements, indicate important changes in the environment and favor positive changes in the lives of children.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21715--00
        • Campus Realengo do IFRJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Legal guardians of children from 0 to 11 years and 11 months of age with clinical diagnosis of nervous system health conditions with motor limitations.

Description

Inclusion Criteria:

  • Legal guardians of children aged up to 11 years and 11 months with motor disability
  • Most be in Physio-therapeutic care at the School Clinic on the Realengo campus of the Federal Institute of Education, Science and Technology of Rio de Janeiro.

Exclusion Criteria:

  • Guardians of children with a health condition associated with the Nervous System without motor limitations
  • Other health conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Caregivers
Caregivers will respond to two of the three questionnaires: PEM-CY or YC-PEM, and PEDI
Other: questionnaires
Application of the questionnaires Measure of Participation and Environment - Children and Youth, (PEM-CY), or Measure of Participation and the environment - young children (YC-PEM), and the Pediatric Disability Assessment Inventory (PEDI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of caregivers/guardians of children with neuromotor disabilities regarding participation in three sections: home, school, and community.
Time Frame: 4 months
Evaluated by PEM-CY and YC-PEM, each item on participation is evaluated in three dimensions: frequency (seven-point scale), involvement (five-point scale) and desire for change (scores from zero to 100%). The environment, in turn, is evaluated by its characteristics, as well as by the availability of services and resources (scores from zero to 100%).
4 months
Perception of caregivers/guardians of children with neuromotor disabilities regarding environmental factors that may be barriers or facilitators in three sections: home, school, and community.
Time Frame: 4 months
Evaluated by PEM-CY and YC-PEM, each item on participation is evaluated in three dimensions: frequency (seven-point scale), involvement (five-point scale) and desire for change (scores from zero to 100%). The environment, in turn, is evaluated by its characteristics, as well as by the availability of services and resources (scores from zero to 100%).
4 months
Perception of caregivers/guardians of children with neuromotor disabilities about the child's performance in daily activities
Time Frame: 4 months
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
4 months
Perception of caregivers/guardians of children with neuromotor disabilities about the child's mobility and the need for caregiver help
Time Frame: 4 months
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
4 months
Perception of caregivers/guardians of children with neuromotor disabilities about the child's need for changes in the environment and in the child
Time Frame: 4 months
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Institute of Rio de Janeiro

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Elisa B Van Eyken, PhD, Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2022

Primary Completion (Actual)

September 25, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 559
  • CAAE 59793122.8.0000.5268 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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